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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

TOPCAT enrolled 3445 patients with heart failure and preserved ejection fraction at 233 academic and community medical centers in 6 countries between August 2006 and January 2012. Trial follow-up ended in June 2013.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Trial randomization was stratified by whether patients were enrolled into the study on the basis of having a hospitalization for heart failure within the past year (N=2,464) or having an elevated natriuretic peptide level within 60 days before randomization (N=981). The second criterion was considered only for those who did not meet the first.

Reporting Groups

Description

Placebo

Placebo of spironolactone

Spironolactone

Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Placebo

Placebo of spironolactone

Spironolactone

Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.

Total

Total of all reporting groups

Baseline Measures

Placebo

Spironolactone

Total

Overall Participants Analyzed [Units: Participants]

1723

1722

3445

Age [Units: Participants]

<=18 years

0

0

0

Between 18 and 65 years

649

654

1303

>=65 years

1074

1068

2142

Age [Units: Years]Median (Inter-Quartile Range)

68.7
(60.7 to 75.5)

68.7
(61.0 to 76.4)

68.7
(60.9 to 75.9)

Gender [Units: Participants]

Female

887

888

1775

Male

836

834

1670

Race (NIH/OMB) [Units: Participants]

American Indian or Alaska Native

3

6

9

Asian

9

10

19

Native Hawaiian or Other Pacific Islander

0

0

0

Black or African American

149

151

300

White

1537

1525

3062

More than one race

0

2

2

Unknown or Not Reported

25

28

53

Region of Enrollment [Units: Participants]

United States

579

572

1151

Canada

160

166

326

Argentina

60

63

123

Brazil

82

85

167

Russian Federation

537

529

1066

Georgia

305

307

612

Eligibility Stratum [1] [Units: Participants]

Hospitalization in previous year for heart failure

1232

1232

2464

Elevated natriuretic peptide in previous 60 days

491

490

981

[1]

Eligible patients were assigned to one of two strata before randomization, according to whether they had at least one hospitalization within the previous 12 months in which management of heart failure was a major component of the care provided, or in absence of that criterion, an elevated brain natriuretic peptide (BNP) level within 60 days prior to randomization (a brain natriuretic peptide [BNP] level ≥100 pg per milliliter or an N-terminal pro-BNP [NTproBNP] level ≥360 pg per milliliter).

Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ]

Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ]

Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure [ Time Frame: Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject. ]

Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First [ Time Frame: Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject. ]

New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline. [ Time Frame: Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject. ]

Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline. [ Time Frame: Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject. ]

Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First [ Time Frame: Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject. ]

Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire. [ Time Frame: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ]